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Streaming Amy
Advair and Other LABA’s Under Scrutiny (Again)
Unlike very few other people with youngish children, I’m awfully relieved this time of year.
I mean, sure, Christmas is coming up with its attendant packed schedule at the girls’ schools on top of the general holiday free-for-all, and this year finds me still (STILL!) preparing for/anticipating this neverending move to Denver.
But.
AG’s Steadfast Sidekick and partner in mayhem had her 7th birthday party this past weekend, and December always runs more smoothly with that behind me.
My younger daughter was born on December 20 but to avoid the lame birthday/Christmas combo most December babies endure and make sure her day doesn’t get lost in the holiday shuffle, she always gets to celebrate during the first week of the month. Now, I’ve got a very firm and sanity-saving rule that restricts birthday parties to every other year for both girls, but it’s still jarring–party or no–to switch gears over from Christmas planning to birthday prep for that week.
So! Party’s over, with a fabulous time had by all. Now on to Christmas.
(deep breath)
The birthday party and AG’s two school projects found me particularly Internetless this weekend, so I didn’t see the following story until Asthmagirl (the blogger, not my kid) emailed it to me:
Disputed warning given on 4 asthma meds
Yep, it’s those pesky long-acting beta agonists again. Namely, Advair, Symbicort, Serevent, and Foradil. If you’re new to this blog or new to the story or new to asthma in general, you can read some background in my previous posts here, here, and here. That first post, especially, includes some good links.
The basics of the story are these:
- LABA use has been associated with death in some (stress on the some) asthma patients. Edited 12/8 to add: As I understand the issue, the potential risk is higher for Serevent and Foradil inhalers, which don’t contain a corticosteroid, than for the combination ones. (Advair and Symbicort) However, Servent and Foradil are both supposed to be used in addition to corticosteroid inhalers.
- Articles on LABA use explore a variety of possible other causes for the deaths, ranging from misuse of LABA inhalers as quick-relief meds–which they are NOT–to overuse that strays from doctor’s instructions to the severity of the asthma or lung condition in the first place.
- Either way, doctors only prescribe meds like Advair when the daily corticosteroids and quick-relief albuterol (like AG’s regimen) just won’t do the job on their own.
Now, there’s a bigger controversy brewing over the meds. It seems two FDA officials have gone on record with the statement that no one should use these meds, and another supports their use in adults but not children.
Quite a lot of people disagree with these positions, including other officials within the FDA, and a committee is meeting this week to discuss the divide. I should note here that whatever risk these drugs do carry, they are without a doubt lifesavers for severe patients:
Whatever the committee’s decision, the drugs will almost certainly remain on the market because even the agency’s drug-safety officials concluded they were useful in patients who have chronic obstructive pulmonary disease, nearly all of whom are elderly.
I can’t make any judgments about the safety of LABA inhalers, of course, being neither a researcher nor a doctor. On top of that, my kid’s been lucky enough to stay under control with daily inhaled corticosteroids, so I can’t even speak from personal experience. But I’ll tell you what I’d do if I were either A) an asthma patient with an LABA prescription and concerns/questions about the safety of it, or B) the parent of a kid with an LABA prescription and I had questions/concerns about the safety of it:
1. I’d talk to my primary care doctor and/or specialist first.
2. I’d keep an eye on the results of the FDA committee meeting this week. You can keep track at WebMD’s new food, medicine, and cosmetic safety page. (in partnership with the FDA)
3. If I or my child had a new prescription for an LABA inhaler, after I completed those two steps I would keep a very, very close eye out for side effects. (And that’s true for any prescription, too.)
I know some of you guys use these drugs or treat patients who use them. What do you think about these new developments?
Filed under: EPA & FDA Fun, Holidays, Lung Drugs, My Asthma Girl & Me, News & Research
Hi Amy. Thought-provoking and informative as always. But I do have some points of opinion. Since I am not the writer you are and therefore don’t have a blog, I’ll use yours as my forum – hope that’s okay. Dear readers at ‘the Blog of Inferior Breathing,’ The following comment does not reflect the opinion of theasthmamom.com.
As Amy stated, the issue with Advair and Symbicourt is not really an issue with the drugs themselves, but more of a problem of improper use. It’s a lot like the well-publicized and tragic deaths of the people who abused (and often unknowingly) ephedra by over-consuming diet pills or energy drinks. Ephedra was a shortcut at best and had many harmful side-effects if over used. But the same can be said of cough medicine. Properly controlled and temporary use of ephedra did help a lot of unhealthy people jump-start weight loss and move toward a more healthy life.
I realize that ephedra was a different case because it’s classified as an herb and is therefore not under the jurisdiction of the FDA. But the argument for its eventual ban is the same.
Consumers seem to have successfully persuaded law-makers that they are not accountable for failing to reading warning labels. Nor are we accountable for straying from recommended dosing. So these two FDA officials think that useful drugs like long-acting beta agonists should be taken out of the hands of the MAJORITY of patients who are NOT experiencing issues?
That’s a great philosophy. But let’s keep cigarettes legal. Zero health benefits, source of known carcinogens, cause of millions of deaths, imbued with addictive chemicals and affects the lives of people who choose not to partake.
Sorry, off on a tangent. I don’t necessarily think cigarettes should be illegal. Nor do I think ephedra should be as easily available as it was before the ban. But I’m tired of the amount of tax dollars and human resource spent on babysitting society because some people don’t read the information available to them. Or because they make personal decisions to ignore their doctors.
Color me confused and concerned… which is why I sent the link to you.
I’ve been using Advair (as directed) for 4 years. I’m aware of the black box warnings that were the result of the studies where Serevent was used inappropriately as a rescue med.
However, I find myself a bit taken aback when 2 FDA guys say the product shouldn’t be on the market. And the third one says “well yeah, but only for the elderly adults with COPD”.
Since I’m neither elderly or encumbered with COPD, I think I’ll put in a call to my fabulous doctor. I don’t know what the plan would be if we decided to nix Advair. Possibly Pulmicort and no LABA? I’ve done well with Foradil but that’s also on the black list.
Overall, I hope this is resolved soon. It’s one thing to charge an arm and a leg for a medication, it’s another to charge that much and then tell people it’s dangerous.
GandW,
Completely agree with you about needing to read the information and follow dr’s. insturctions, but I think the medical community, too, needs to make sure they’re telling parents and patients when that information changes. Also, just wanted to clarify that my post isn’t claiming to know the problems behind LABA’s but offering up the current theories instead.
Asthmagirl,
This absolutely needs to be resolved soon–all the news/opinions floating around right now are confusing, to say the very least. I can’t imagine these will be taken off the market because of the lack of alternatives for COPD patients and severe asthmatics. I wonder how I’d feel if my kid was using one of these inhalers right now? Advair wasn’t approved for kids aged 4 to 11 until AG was 5–I’m fairly certain she would have been prescribed it otherwise.
Cripes, I responded on the wrong post:
My mom mentioned something about this yesterday, but I just now was able to get on the computer and saw your post about it. For us this is a huge issue. Alorah is going to be 7 next month. She failed pulmicort, she failed Flovent, she is now on Advair 250/50-her asthma IS that bad. She went from blowing 150’s on her peak flow to 240. She has not needed her albuterol in 2 weeks. For us we have seen a HUGE improvement in a) her energy b) her lung function and c) her flares. There is no doubt it is working. After she had 3 attacks in three weeks all needing 4-6 days of Pediapred (and all the risks that med carries with it) and doing Flovent for 2 months and having another major flare we have finally found something that works. I give it to her an hour before she goes to school so I can watch her. I give it to her at least an hour, sometimes 2, before bed so I can watch her. So far, so good. I honest to goodness do not know what we will do if they pull this med for kids. She was on the verge of ending up in the hospital in September, now she can run and play like a normal kiddo, no albuterol. I will be on pins and needles until we get the decision of the board. I’m glad they are being cautious but I am absolutely freaked out about going through another trial with med after med to find something else that works….
LOL…no problem. It sounds like you have a good observation/dosage schedule going and I know there are lots of patients and parents like you. And really–what’s the alternative for patients that can’t attain good control otherwise? Prednisone, as you mentioned, carries all sorts of nasty side effects I think we’re all a little too familiar with.
And I really don’t think anyone wants to go back to the days of theophylline.
I’m glad it’s working for your daughter–hopefully this will just result in stronger warnings and/or stricter prescribing guidelines.
I have to agree with George & wheezy, it’s the improper use of the LABA’s that causes most of the problems.
These LABA’s are much more potent than the short acting beta agonists , so of course if take too much you’re asking for trouble.
My Physicians have been monkeying around with Advair, Singular, and Spiriva for 6 mos now. My asthma is pretty much induced by allergens as most peoples are, stress plays a factor also. I have had no problems with Spiriva inhaled, but major problems with Advair, Thrush being a major player and harming my vocal cords being minor to the medication made my chest tighten rather than open up. Three different physcians are involved in my treatment, Cardio/ Pulmonary, ENT and my Primary, each takes me off then puts me back on the Advair, until I finally told them enough… we tried the non powedered inhaler of Advair, same result. I am now trying out Alvesco, something new and a different medication than the Adviar, This we recently Jan. 08 approved by the FDA… but in so much as the screen by the FDA has become so much less intense in hopes of getting medications out there to help… I still am crossing my fingers on this one.. that at some point they won’t find the need to Black Box it… and it will be what all asmatics hope for…. one medication…. no more fears.
I am going to add that recently I was involved in blind discussion groups involving asthma. In the sessions I attended. Advair seemed to be constantly brought up as a drug creating problems from increased heart rate, and blood pressure, to my problems with getting a full breath and the tight feeling in the lungs which restricted my breathing. In a group of 16, I was the only member still on Advair at that time, all but two had been prescribed the medication and it had been removed from their treatment.
Stephen–
Thanks for your doubly-valuable input as a patient and former RT. I always hesitate to weigh in on meds my kid hasn’t used.
Lora–
Welcome to the site, and thanks for your insightful comment–esp. re: Advair and the discussion groups.
Are you using Alvesco exclusively since it’s just an inhaled corticosteroid and not a combination inhaler like Advair?
I hope it works well for you, either way.
I just discovered your site and LOVE it. My five year old son takes Advair for his moderate persistent asthma. He was on flovent last year with little success — and several courses of prednisone as a result. Advair has been just amazing. I’m fairly terrified by the possible DEATH side effect, but equally scared of what would happen if it wasn’t available for him anymore. I wonder how many FDA investigators give Advair to their kids?
Hey, thanks
Don’t know if you’ve stayed up-to-date on the topic, but you can read more recent news and a link to the FDA’s decision here.
The short version: Advair’s not getting pulled off the market, and Serevent and Foradil are riskier.
[...] talking about AG’s Steadfast Sidekick who, as you may recall, turns seven this Saturday and had her party over a week [...]
[...] Safety of Long-Acting Beta Agonists Drugs like Advair were under scrutiny pretty much all year, with the debate coming down to whether the possible serious side effects are worth the very real benefits of the medicine. As it stands now, the FDA is pulling none of them off the market (for any age group), but its drug safety division doesn’t want any of them marketed for children. [...]